Device
els extra low shrinkage® composite (els composite for short) is a light-curing, highly filled, radiopaque micro hybrid composite with extremely
Manufacturer
Saremco Dental AG
Saremco Dental AG
Model: A3
Catalog: 7101
DI: D93171011
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-04-28
Current Version: 2026-05-06
Description
els extra low shrinkage® composite (els composite for short) is a light-curing, highly filled, radiopaque micro hybrid composite with extremely
low shrinkage stress for permanent anterior and posterior restorations. els extra low shrinkage® composite is a polymer-based restorative
material, Type 1, Class 2, Group 1 and 2 according to DIN EN ISO 4049
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
01f9a793-d2b6-422f-9275-55ad9bf26afd
Distribution Status:
In Commercial Distribution
DUNS Number:
480619001
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
D93171011
Type:
Primary
Issuing Agency:
HIBCC
GMDN
Code: 35870
Name: Dental composite resin
Definition:
A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
FDA Product Codes
EBF
Material, Tooth Shade, Resin
Premarket Submissions
Submission Number:
K240823
Supplement Number:
000